K242485
- 510(k) number
- K242485
- Device name
- EveryWare
- Applicant
- Breas Medical AB SE
- Product code
- MOD — Accessory To Continuous Ventilator (Respirator)
- Decision date
- 2025-05-20
- Date received
- 2024-08-21
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Anesthesiology
PDFDownload 510(k) SummaryArchived here · 0.3 MB · U.S. public domain
Also available from FDA: K242485.pdf
Official FDA record: K242485
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.